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FDA Eliminates Animal Testing: Impact on Biotechs

The Premier Consulting Blog

On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).[ 2] An overview of the 3Rs The FDA and other global regulatory health authorities have long embraced the 3Rs of animal research (replace, reduce, and refine).

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The evolution of AI in drug discovery: learning from history’s mistakes (Part 2)

Drug Target Review

Having previously drawn parallels with industry adoption of electronic lab notebooks in part 1 , this article expands on his vision for the future of the industry, sharing his forward-thinking ideas and practical recommendations. Currently, understanding these aspects requires extensive animal testing followed by human trials.

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Future-proofing drug development with GenAI

Drug Target Review

New approach methodologies data In April, the US Food and Drug Administration (FDA) announced a plan to replace animal testing in the development of monoclonal antibodies and other therapies with validated “human-relevant” methods, including AI-based computational models evaluating toxicity, cellular lines and organoid toxicity.

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Time for change: non-human primates in drug research

Drug Target Review

The FDA’s new roadmap In April 2025, the FDA announced a major regulatory shift with its plan to phase out the requirement for animal testing in the development of monoclonal antibodies and other drugs, when scientifically appropriate. NIH Office of Laboratory Animal Welfare – Training Guidelines. Bailey J, et al.

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A global push for better animal welfare in research

Drug Target Review

Complex challenges in reducing animal use One of the most pressing issues Liz highlights is the misconception that animal testing can be eliminated entirely in the near future. Microphysiological systems and other non-animal models are incredibly promising, but they’re not a total replacement,” she cautions.

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Commission unveils details on plan for phasing out animal testing for chemicals safety

Agency IQ

BY SCOTT STEPHENS, MPA At the REACH and CLP regulators’ meeting in July, the European Commission revealed specifics about its formal schedule to eliminate animal testing used for chemical safety assessment. Fill out the form to read the full article.

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4 ways ex vivo models offer Pharma better alternatives to animal testing

Reprocell

Pharma companies are legally required to test novel drugs in animal models before beginning human trials. And while animal testing has progressed thousands of therapeutics that we use today, it is not without its experimental and ethical downfalls.